BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2839606 · Received November 1, 2012

    Report

    Report Number
    2839606
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION, INC
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD AN OCCIPITAL NERVE GENERATOR PLACED AND IMPLANTABLE PULSE GENERATOR (IPG) PLACED ON HER ANTERIOR CHEST (04/2012). SHE RECENTLY BEGAN EXPERIENCING RECURRENT PAIN. IT WAS DISCOVERED BY X-RAY THAT HER LEADS HAD MOVED AND HER ANTERIOR IPG WAS CAUSING HER PAIN. THE OLD SPINAL CORD GENERATOR AND IPG WERE REMOVED AND REPLACED.======================MANUFACTURER RESPONSE FOR SPINAL CORD STIMULATOR, SPINAL CORD STIMULATOR GENERATOR (PER SITE REPORTER).======================WILL INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ST. JUDE MEDICAL NEUROMODULATION, INC 3788 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR